# K904263: Dacron R Surgical Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Sharppoint, Inc.
- Decided: Oct 16, 1990 after 29 days
- Product code: GAS (Suture, Nonabsorbable, Synthetic, Polyester)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060165: Axyaflex Polyester Suture (2006), 11 descendants of its own
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K173747: Rexlene (2018), 1 descendant of its own
- K180701: SafePath Suturing System (2018), 1 descendant of its own

Source page: https://510kreport.com/device/K904263
Methodology: https://510kreport.com/methodology